{"id":"AIBD-0959","title":"China's CMDE finds that doctors reading prostate MRI with AI-Rad Companion Prostate MR diagnosed lesions slightly better in the maker's trial","summary":"In the maker's trial that China's CMDE reviewed, doctors reading prostate MRI with AI-Rad Companion Prostate MR reached an AUROC of 0.7010, against 0.6758 without it.","date_observed":"2025-10-29","date_basis":"source publication","date_precision":"day","benefit_status":"intended","source_collection":null,"source_entry":null,"account":"AI-Rad Companion Prostate MR is Siemens Healthineers software that uses deep learning to help doctors detect suspected prostate adenocarcinoma on MR images of untreated adults aged 40 and over. The applicant for Class III registration in China was 上海西门子医疗器械有限公司 (Siemens Shanghai Medical Equipment). The Center for Medical Device Evaluation (CMDE) of China's National Medical Products Administration reviewed the file. The trial was the maker's own, a retrospective multicenter multi-reader multi-case study with 12 doctors and 340 subjects. For case-level diagnosis of prostate lesions, the AUROC was 0.7010 with the software and 0.6758 without, a difference of 0.0252 (95% CI 0.0011 to 0.0493). Lesion-level sensitivity was 69.4% against 65.0%, a difference whose confidence interval included zero. Median reading time was 98 seconds in both groups. On 29 October 2025, CMDE concluded that “该产品上市带来的受益大于风险” (the benefits of putting the product on the market outweigh the risks) and recommended approval. The doctors read stored images, so the software guided no care. 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Section 三、临床评价概述 (clinical evaluation).","title":"医疗器械产品注册技术审评报告：前列腺癌磁共振图像辅助检测软件（CQZ2401376）","url":"https://www.cmde.org.cn/directory/web/cmde/images/1765243681648031434.pdf","date":"2025-10-29","written_by":"independent","quote":"主要有效性评价病例水平前列腺病变诊断的 ROC 曲线下面积 AUROC：试验组为 0.7010，对照组为 0.6758，两组之差为0.0252，95%置信区间为（0.0011，0.0493），95%置信区间下限大于优效界值"},{"kind":"regulatory document","citation":"Center for Medical Device Evaluation (CMDE), National Medical Products Administration, China. 医疗器械产品注册技术审评报告：前列腺癌磁共振图像辅助检测软件 (technical review report for the registration of prostate cancer MR image detection-aid software), acceptance no. CQZ2401376, applicant 上海西门子医疗器械有限公司. 29 October 2025. Section 四、产品受益风险判定 (benefit-risk determination), CMDE's own judgment of benefit and risk.","title":"医疗器械产品注册技术审评报告：前列腺癌磁共振图像辅助检测软件（CQZ2401376）","url":"https://www.cmde.org.cn/directory/web/cmde/images/1765243681648031434.pdf","date":"2025-10-29","written_by":"independent","quote":"经综合评价，在目前认知水平上，认为该产品上市带来的受益大于风险，综合剩余风险可接受。"},{"kind":"other","citation":"Siemens Healthineers. AI-Rad Companion: AI-powered radiology workflow solutions (product page), section AI-Rad Companion Prostate MR. 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